New Actemra Clinical Trials Move Forward

August 22, 2017 | Pharmaceutical Litigation

Even as questions swirl about the drug’s safety, Roche subsidiary Genentech announced that its plans to market Actemra to sclerosis patients will move to Phase 3 clinical trials.

Over the next 48 weeks, Genentech employees at over 100 worldwide sites will administer either tocilizumab or placebos to test subjects who have been diagnosed with systemic sclerosis, a rare and incurable condition in which inflamed finger joints cause the tissue to harden and lose its flexibility; the Actrema subjects will continue receiving the drug for an additional 48 weeks thereafter. In a statement, Genentech Rare Disease Head Dr. Jeffrey Siegel said he hoped that the trial would introduce “a therapeutic option to a patient population that has serious unmet need.” The trial is also designed to clarify the relationship between Actemra and lung disease, he added.

In June 2015, the Food and Drug Administration declared tocilizumab to be a breakthrough sclerosis therapy and placed Actemra on a fast track to approval.

Actemra and Serious Side Effects

All drugs, from children’s aspirin to LSD, have side effects. In many cases, the connection is easy to establish and therefore the risk is easy to minimize. For example, Actemra elevates blood cholesterol levels, raising the risk of serious cardiac episodes among individuals who, in many cases, are already prone to such incidents. In fact, since U.S. regulators approved the drug for sale in 2010, the Food and Drug Administration has received over 1,100 reports of Actemra-related fatalities, mostly triggered by adverse cardiac episodes.

Most likely to boost drug sales, Roche failed to warn patients about the elevated risk, and the legal implications of this failure are discussed below.

Other side effects are more difficult to pin down, which is why Roche is so concerned about the link between Actemra and Interstitial Lung Disease, an umbrella term which describes a large group of health problems, including often-deadly asbestosis.

After long term exposure to certain toxic substances, a list that obviously includes tocilizumab, excessive scar tissue builds up in the lungs, eventually compromising the patient’s ability to breath and causing oxygen deprivation to vital organs. Additionally, some particularly strong anti-inflammatory drugs, and Actemra is one of the strongest ones known to medical science, may work too well and not only reduce unwanted inflammation but also compromise the lung’s ability to expand and contract.

As if the disease itself was not bad enough, ILD often triggers serious complications, such as cor pulmonale (partial heart failure) and pulmonary hypertension (high blood pressure in the lungs).

Other Actemra complications include an elevated risk of pancreatitis, a serious illness that is often a precursor to pancreatic cancer.

Legal Issues

While scientists and doctors wrestle with questions of cause and effect, plaintiffs in negligence cases are under no such constraints, because of the level of proof required. If plaintiffs establish that their damages were connected to dangerous drugs, they are entitled to compensation, regardless of the specifics.

If a product manufacturer does not alert customers about all the known potential risks, the manufacturer may be strictly liable for damages, per the failure to warn theory. Strict liability means that the defendant is responsible for damages as a matter of law, regardless of any good intentions or exercise of caution that the manufacturer may have demonstrated.

In addition to cause, victim/plaintiffs must also establish nonobviousness in failure to warn cases. Bathtub manufacturers do not need to notify consumers that small children could drown in their products, because that danger is obvious. However, drug manufacturers should warn patients about all the known side effects, because the danger is hidden and these victims have no other way to learn about the hazard.

In failure to warn and other dangerous drug cases, such as breach of warranty or design defect, defendants are liable for victims’ monetary losses, such as their medical bills, and noneconomic losses, such as emotional distress. Moreover, to punish the defendant and deter future wrongdoing, defective product juries normally award substantial punitive damages.

The Regulatory Process

The furor over Actemra is an indictment not only of Roche, but also of the Food and Drug Administration, because this agency is clearly no longer the consumer watchdog that it was in decades past.

For example, the FDA often uses regulatory loopholes to expedite the approval process and allow the drug companies to make more money. One is the 510(k) protocol, which allows regulators to essentially rubber-stamp devices or drugs which are “substantially similar” to products already available. Unfortunately, there is simply no guarantee that the “substantially similar” product is safe and effective, and give the FDA’s refusal to thoroughly examine 510(k) products, these safety issues may be magnified in the new product.

In 2012, the FDA modified its rules to allow for breakthrough designations, which apply to any new drugs that effectively “treat a serious or life threatening disease” and are a “substantial improvement over existing therapies.” Per the rules, safety is absolutely not a consideration.

Often, by the time the FDA takes corrective action, many victims have already been seriously injured.

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